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A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
The primary objective of this study is to compare the efficacy, safety, and tolerability of IDP-120 Gel to IDP-120 Component A, IDP-120 Component B, and IDP-120 Vehicle Gel in subjects with moderate to severe acne vulgaris.
Details
| Lead sponsor | Valeant Pharmaceuticals |
|---|---|
| Phase | Phase 2 |
| Status | UNKNOWN |
| Enrolment | 350 |
| Start date | 2015-10 |
| Completion | 2016-09 |
Conditions
- Acne Vulgaris
Interventions
- IDP-120 Gel
- IDP-120 Component A
- IDP-120 Component B
- IDP-120 Vehicle Gel
Primary outcomes
- Absolute change from Baseline to Week 12 in mean inflammatory lesion counts — 12 weeks
At each visit the Evaluator will count the total number of inflammatory lesions (papules, pustules, and nodules) on the subject's face. Inflammatory lesions are defined as follows: Papule - a small, solid elevation less than 5 mm in diameter. Most of the lesion is above the surface of the skin. Pustule - a small, circumscribed elevation less than 5 mm in diameter that contains yellow-white exudate. Nodule - a subcutaneous lesion greater than or equal to 5 mm in diameter. - Absolute change from Baseline to Week 12 in mean non-inflammatory lesion counts — 12 weeks
At each visit the Evaluator will count the total number of non-inflammatory lesions (open and closed comedones). Non-inflammatory lesions are defined as follows: Open comedones (black head) - a lesion in which the follicle opening is widely dilated with the contents protruding out onto the surface of the skin. Closed comedones (white head)- a lesion in which the follicle opening is closed, but the sebaceous gland is enlarged by the pressure of the sebum build up, which in turn causes the skin around the follicle to thin and become elevated with a white appearance. - Percent of subjects who achieve at least a two-grade reduction from baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score. — 12 weeks
At each visit the severity will be determined based on evaluator-blinded evaluations of the signs and symptoms of acne vulgaris. Evaluations will be scored on a scale of 0-4 (Evaluator's Global Severity Score), with 0 being clear and 4 being severe. Please see below for complete definitions. 0\. Clear - Normal, clear skin with no evidence of acne vulgaris 1. Almost clear- Rare non-inflammatory lesions present, with rare non-inflamed papules (papules must be resolving and may be hyperpigmented, though not pink-red) 2. Mild- Some non-inflammatory lesions are present, with few inflammatory lesions (papules/pustules only; no nodulo-cystic lesions) 3. Moderate-Non-inflammatory lesions predominate, with multiple inflammatory lesions evident: several to many comedones and papules/pustules, and there may or may not be one nodulo-cystic lesion 4. Severe- Inflammatory lesions are more apparent, many comedones and papules/pustules, there may or may not be up to 2 nodulo-cystic lesions.